Anna-Luisa Schaffgotsch, Founder and CEO of Impli, knows what it’s like to go against the grain. When she started the company in 2019 with the belief that implants could help improve health outcomes, not everyone shared her enthusiasm. She talks to us about persevering against the odds through the unchartered territory of precision monitoring for in vitro fertilisation (IVF).

When Anna-Luisa Schaffgotsch first came up with the idea behind her company Impli, she knew she was embarking on a rocky journey. Her vision was this: smartwatches – with their ability to track activity levels, heart rate and sleep patterns – are undoubtedly impressive, but they have limitations. They can’t measure the levels of glucose, hormones or other molecules in our blood. Anna-Luisa saw an opportunity for implants – biosensor devices that sit just under the skin – to unlock deeper insights about our health.

‘When we first started back in 2019,’ Anna-Luisa tells us, ‘people thought we were crazy. They didn’t see the value of implants, and there was a lot of fear around what might happen to their data. But we had expected these reactions. When you start a company in a novel space, you have to be resilient, stick to your vision and push forward.’

And this is what Anna-Luisa did. Initially based in the UK, she soon took the company to Switzerland, where its manufacturer was based. ‘This gives us the best of both worlds: the UK’s early-stage innovation ecosystem and Switzerland’s expertise and health ecosystem.’

Soon after getting set up in both countries, COVID-19 hit. As for many other start-ups, this was a difficult time, but there were a couple of silver linings for Impli. Significantly, people’s mindset towards healthcare changed. ‘There was a lot of talk about data and privacy, and people became more aware of how data is handled. This understanding dispelled fears. They also became aware that other technologies, like mobile phones, can be far more intrusive than implants.’

It was also during this period that Anna-Luisa had the opportunity to sit down with clinicians, conduct research and figure out Impli’s business strategy. Having applied for Biopôle’s Vanguard Accelerator programme, the entrepreneur benefited from help from a range of experts: ‘The Vanguard allowed us to look at our solution from a digital angle. We gained a huge network that we still rely on to this day. It’s hard to overstate how valuable this has been. A strong network drives funding and relationships with big companies. It drives growth in the future. The Vanguard programme was a fantastic launchpad for us.’

After exploring different spaces – such as cardiology and glucose monitoring – Anna-Luisa decided to focus on women’s health. It made sense: with no big medical device company in this area, there was a clear gap in the market. But her motivation also stemmed from personal experience: ‘My co-founder and I had been affected by hormone imbalances, like all women at some point in their lives – whether it’s with pregnancy and birth, menopause or the menstrual cycle. We knew that by going into women’s health, we’d have the biggest impact. We knew there would be a large market. We also believed we could help women, which was hugely motivating.’

Specifically, Anna-Luisa decided to develop precision monitoring for IVF treatment. Currently, women who undergo IVF treatment visit a clinic for blood tests several times a week. This frequency is far from ideal, especially for women going through a very taxing medical process. And often, doctors don’t get the data they need from blood tests because hormones fluctuate. Anna-Luisa tells us how Impli’s solution can help: ‘Our implant measures estradiol, progesterone and luteinising hormone in real time so doctors can make precise decisions. When we look at how hormones behave over time – and this is different for each patient – we gain a fuller picture. This allows doctors to dose hormones in a tailored way. Ultimately, our aim is to provide safer IVF treatments, with fewer side effects and better outcomes.’

Women’s health has gained attention and investment in recent years, but in 2019 it was still widely ignored. Anna-Luisa recalls: ‘In several investor meetings, I had to explain why an Apple Watch can’t measure hormones. Many people had simply never come across or thought about the fact women may have different healthcare needs to those of men. In the last few years, the media has done a great job at explaining why women’s health is important.’

A difficulty intrinsic to the field, which start-ups like Impli must navigate, is that the medical system chronically discriminates against women. Often, only men are included in clinical trials, leading to a lack of sex-disaggregated data. This is harmful for women, since their bodies are different to those of men and thus react differently to drugs and vaccines.

This discrimination starts very early on in medical research. ‘About three years ago, we asked a reasonably large research organisation in the UK for animal trials,’ says Anna-Luisa. ‘We told them we needed female animals, and they said they had never dealt with female animals. They seemed confused about why we would even want to work with female animals – they had never come across this before. I was shocked. The implications of this are very worrying.’

Female animals do add an extra layer of complexity to drug trials because of their hormonal cycles. If researchers don’t track or control for where each animal is in its cycle, these natural hormone fluctuations can affect research findings. Accounting for sex at this stage is crucial to creating fair and accurate outcomes down the line.

Aside from challenges specific to women’s health, Anna-Luisa reflects on the wider pressures of building a biotech company. ‘We’ve had a tough couple of years. The industry wasn’t doing too well for a while, and it was difficult to raise funds. But we survived it and we’re now closing a round of funding. If all goes well, we’ll go to market in 2028.’

Anna-Luisa is candid about the realities of building a biotech company from scratch:  ‘Sometimes you want to quit and get a job in an industry instead, but then you look at your north star and realise the importance of your contribution and the bigger picture.

Entrepreneurship is sometimes idealised, when in fact it’s a difficult and lonely journey. We need to make sure we have really strong ecosystems in place – with people who believe in our mission and will support us each step of the way.’